Short title

This Act may be cited as the

Pulmonary Fibrosis Research Enhancement Act

Findings

Congress makes the following findings: (1)Pulmonary fibrosis (in this section referred to as PF) is a relentlessly progressive, ultimately fatal disease that affects the lungs, gradually robbing a person of the ability to breathe. (2)More than 128,000 individuals may be living with PF in the United States; 48,000 individuals in the United States are diagnosed with PF annually; and as many as 40,000 die annually. (3)Prevalence of PF has increased more than 150 percent since 2001, and is expected to continue rising as the population of the United States ages. (4)The median survival rate for a person with PF is 2.8 years. (5)More than 50 percent of PF cases are initially misdiagnosed as other forms of respiratory illness before being correctly diagnosed as PF, and more than 58 percent of patients go more than a year with symptoms before being diagnosed correctly. (6)The cause of most forms of PF is not well understood, and in most cases is unknown, though there is growing evidence that one cause of PF may be environmental or occupational exposure to pollutants. (7)There is no Food and Drug Administration-approved treatment or cure for PF. (8)Public awareness of PF remains low compared to rare diseases of lesser prevalence, despite PF’s increasing prevalence. (9)There has been no federally funded national awareness or educational effort to improve understanding of PF in the public or medical communities, though nonprofit patient education and research groups have begun to increase awareness. The first Federal legislation expressing Congress’ support for PF research, H. Con. Res. 182, was agreed to by both Houses of Congress in 2007.

Pulmonary fibrosis registry

Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 317S the following:

317T.

Pulmonary fibrosis registry

(a)

Establishment

(1)

In general

Not later than 1 year after the receipt of the report required by subsection (b)(3), the Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with patients, patient advocates, and others with expertise in research and care of pulmonary fibrosis (referred to in this section as PF), shall— (A)develop a system to collect data on PF and other interstitial lung diseases that are related to PF, including information with respect to the incidence and prevalence of the disease in the United States; and (B)establish a national registry (in this section referred to as the National PF Registry) that— (i)is used for the collection and storage of data described in subparagraph (A); and (ii)includes a population-based registry of cases in the United States of PF and other interstitial lung diseases that are related to PF. (2)

Purpose

The purpose of the National PF Registry shall be to gather available data concerning— (A)PF, including the incidence and prevalence of PF in the United States; (B)environmental and occupational factors that may be associated with the disease; (C)age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease; (D)pathogenesis of PF; and (E)other matters as determined appropriate by the Secretary. (3)

Implementation

Implementation of the National PF Registry shall begin not later than 180 days after the date of the enactment of this section. (b)

Advisory Board

(1)

Establishment

Not later than 90 days after the date of the enactment of this section, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a board to be known as the National Pulmonary Fibrosis Advisory Board (in this section referred to as the Advisory Board). The Advisory Board shall be composed of at least one member, to be appointed by the Secretary, acting through the Director of the Centers for Disease Control and Prevention, representing each of the following: (A)The National Institutes of Health. (B)The National Institute of Environmental Health Sciences. (C)The Department of Veterans Affairs. (D)The Agency for Toxic Substances and Disease Registry. (E)The Centers for Disease Control and Prevention. (F)Patients with PF or their family members and other individuals with an interest in developing and maintaining the National PF Registry. (G)Patient Advocates. (H)Clinicians with expertise on PF and related diseases. (I)Epidemiologists with experience working with data registries. (J)Geneticists or experts in genetics who have experience with the genetics of PF or other neurological diseases. (K)Others with expertise in research and care of PF. (2)

Duties

The Advisory Board shall— (A)review information and make recommendations to the Secretary concerning— (i)the development and maintenance of the National PF Registry; (ii)the type of information to be collected and stored in the National PF Registry; (iii)the manner in which such data is to be collected; (iv)the use and availability of such data, including guidelines for such use; and (v)the collection of information about diseases and disorders that primarily affect the lungs that are considered essential to furthering the study and cure of PF; and (B)consult with the Director of the Centers for Disease Control and Prevention regarding preparation of the National Pulmonary Fibrosis Action Plan under section 5(a) of the Pulmonary Fibrosis Research Enhancement Act. (3)

Report

Not later than 1 year after the date on which the Advisory Board is established, the Advisory Board shall submit to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Health, Education, Labor, and Pensions Committee of the Senate a report on the review conducted under paragraph (2), including the recommendations of the Advisory Board resulting from such review. (c)

Grants

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants to, and enter into contracts and cooperative agreements with, public or private nonprofit entities for the collection, analysis, and reporting of data on PF and other interstitial lung diseases that can be confused with PF, be misdiagnosed as PF, and in some cases progress to PF. (d)

Coordination with State, local, and Federal registries

(1)

In general

In establishing the National PF Registry under subsection (a), the Secretary shall— (A)identify, build upon, expand, and coordinate among existing data and surveillance systems, surveys, registries, and other Federal public health and environmental infrastructure wherever possible, including— (i)existing systems in place at universities, medical centers, and government agencies; (ii)State-based PF registries, National Institutes of Health registries, and Department of Veterans Affairs registries, as available; and (iii)any other relevant databases that collect or maintain information on interstitial lung diseases; and (B)provide for research access to PF data in accordance with applicable statutes and regulations, including those protecting personal privacy. (2)

Coordination with NIH and Department of Veterans Affairs

Consistent with applicable privacy statutes and regulations, the Secretary shall ensure that epidemiological and other types of information obtained under subsection (a) is made available to the National Institutes of Health and the Department of Veterans Affairs. (e)

Authorization of Appropriations

There are authorized to be appropriated to carry out this section $5,000,000 for fiscal year 2009 and $2,500,000 for each of the fiscal years 2010 through 2013.

Pulmonary fibrosis research expansion

Subpart 2 of part C of title IV of the Public Health Service Act (42 U.S.C. 285b et seq.) is amended by adding at the end the following:

424C.

Pulmonary fibrosis research expansion

The Director of the Institute is encouraged to expand, intensify, and coordinate the activities of the Institute with respect to research on pulmonary fibrosis, as appropriate.

National Pulmonary Fibrosis Action Plan

(a)

In General

(1)

Preparation of plan

The Director of the Centers for Disease Control and Prevention, in consultation with the National Pulmonary Fibrosis Advisory Board established under section 317T of the Public Health Service Act, as added by section 3 of this Act, shall prepare a comprehensive plan (in this section referred to as the National Pulmonary Fibrosis Action Plan). (2)

Report to Congress

Not later than one year after the date of the enactment of this Act, the Director of the Centers for Disease Control and Prevention shall submit the National Pulmonary Fibrosis Action Plan to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. (b)

Content

The National Pulmonary Fibrosis Action Plan shall— (1)focus on strategies to increase public education and awareness of pulmonary fibrosis; (2)accelerate patient education strategies, with respect to pulmonary fibrosis, nationwide; (3)address the need for new physician education strategies to improve diagnosis and treatment standards with respect to pulmonary fibrosis; (4)assess and monitor the costs of pulmonary fibrosis and its burden on patients and families; and (5)develop such strategies in partnership with patients, patient advocates, and others with expertise in research and care of pulmonary fibrosis. (c)

Authorization of appropriations

There are authorized to be appropriated to carry out this section $1,000,000 for fiscal year 2009.

National summit

(a)

In general

Not later than one year after the date of the enactment of this Act, and every three years thereafter, the Secretary of Health and Human Services shall convene a summit of researchers, representatives of academic institutions, Federal and State policymakers, public health professionals, and patients, patient advocates, and others with expertise in research and care of pulmonary fibrosis to provide a detailed overview of current research activities at the National Institutes of Health, as well as to discuss and solicit input related to potential areas of collaboration between the National Institutes of Health and other Federal health agencies, including the Centers for Disease Control and Prevention, related to research, prevention, and treatment of pulmonary fibrosis. (b)

Focus Areas

The summit convened under subsection (a) shall focus on— (1)a broad range of research activities relating to the epidemiology and pathogenesis of pulmonary fibrosis; (2)clinical research for the development and evaluation of treatments for pulmonary fibrosis; (3)translational research on evidence-based and cost-effective best practices in the treatment, prevention, and management of pulmonary fibrosis; (4)information and education programs on pulmonary fibrosis for health care professionals and the public; (5)priorities among the programs and activities of the various Federal agencies regarding pulmonary fibrosis; and (6)challenges and opportunities relating to pulmonary fibrosis for scientists, clinicians, patients, and patient advocates . (c)

Report to Congress

Not later than 180 days after the first day that the summit convenes under this section, the Director of the National Institutes of Health shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report that includes a summary of the proceedings of the summit and a description of pulmonary fibrosis research, education, and other activities that are conducted or supported through the national research institutes of the National Institutes of Health. (d)

Public information

The Secretary of Health and Human Services shall make readily available to the public information about the research, education, and other activities relating to pulmonary fibrosis and other related diseases conducted or supported by the National Institutes of Health.